Mesh for POP repair and Its controversies

1. Role of vaginal mesh in current
practice
Dato Dr Aruku Naidu MD, FRCOG, CU
Consultant Urogynaecologist
Hospital Raja Permaisuri Bainun
www.aruku.naidu.blogspot.com

4. INTRODUCTION
• 50% parous women have some degree of POP although only
10% are symptomatic
• 11-12% risk of prolapse surgery in women reaching 79 years of
age
• A re-operation rate of 30% has been reported; some studies
quote a recurrence risk as high as 33-45%
• The need to improve outcome of traditional non-mesh repairs
has led to increased use of mesh augmented pelvic floor repairs
• Aim of mesh incorporation during pelvic floor surgeries is to
result in repairs that are safe, effective & durable

5. BACKGROUND
• There is significant risk of re-operation/ recurrence after pelvic
reconstructive surgery ( 33-45%)
• To improve the outcome, use of synthetic materials was
incooperated during POP surgeries
• This was after success story of mesh hernia repair by surgeons
since 1997
• The use of synthetic mesh augmented pelvic floor repairs was
introduced in 2001
• Mesh industries paid significant role in rapid proliferation of Mesh
usage for POP surgeries. Multi billion indudtry
• Pelvic surgeons with Fellowship training background & those
without ( no clinical guidance) also start using meshes as a result
of industrial push

6. Continued…
• Whilst on one hand SUS using synthetic meshes are currently the
GOLD STANDARD for surgical management of SUI with a success
rate of 81% at 7 years follow up, there is a paucity of high quality
evidence to support the routine use of synthetic meshes for
augmentation of pelvic floor repairs
• The 4th International Consultation for Incontinence Committee
for POP review concluded that there are insufficient data to make
any definitive conclusions with regard to the role of biologic or
synthetic prosthetic materials in primary or recurrent prolapse
surgery

8. Debate: Transvaginal Mesh For POP – the recent
FDA update
“Time to rethink: An evidence based response from pelvic surgeons to
the FDA Safety Communication: “UPDATE on Serious Complications
Associated with Transvaginal Placement of Surgical Mesh for POP”
This is to inform health care providers & patients that serious
complications with placement of mesh are NOT RARE & that it is not
clear that these repairs are MORE EFFECTIVE than non mesh repair
(Based on a systemic review of the scientific literature from 1996-2011 conducted by the FDA)
Int Urogynecol J DOI 10.1007/s00192-011-1581-2

9. Mesh history …
• Amid (1997) categorized synthetic materials used in abdominal
hernia based on “pore size” & “fibre type”
• Deprest et al : Published the physical properties & host
response to implants in POP repair.
• Unique mesh characteristics essential for POP repairs are:
1. Ease of use
2. Capability of host tissue to incorporate the mesh with reduced risk
for erosion, infection & extrusion
3. Non-carcinogenic

10. WHAT IS THE OBJECTIVE OF
USING MESH ?
• Substitution or replacement of lacking
supportive tissue
• Reinforcement of weak or defective
supportive native tissues
• Induction of new supportive tissue &
consolidation to compliment traditional
surgical techniques

11. IT IS SOMETIMES UNCLEAR WHETHER COMPLICATIONS
ASSOCIATED WITH THE USE OF MESH ARE CAUSED BY:
• The surgical technique
• By the synthetic mesh utilized
Nevertheless, clinicians understanding of mesh-related
complications & their proper management, combined
with careful case selection, would result in an improved
outcome!

12. TYPES OF MESHES
• Biological Meshes:
• Autologous grafts (rectus sheath, fascia lata etc)
• Cadaveric fascia lata, dura mater
• Bovine/porcine zenographs (eg. Pelvicol)
• Risk of viral/prion transmission
• Older ones “disappear” after a while
• Non-biological meshes:
1.Absorbable meshes, eg. polyglactin (Vicryl,
Dexon)
2.Non-absorbable meshes

13. NON-ABSORBABLE MESHES
• Type I (macroporous, pores > 75um):
• allows entry of fibroblasts, macrophages
• More resistant to infection, erosion
• eg. polypropylene (Prolene, Gynecare)
• Type II (microporous, pores < 75um):
• eg. Gore-Tex
• Type III (combined micro & macroporous):
• eg. Teflon, mersilene
• Type IV (Submicronic):
• eg. silastic

14. ANTERIOR VAGINAL WALL
RECONSTRUCTION WITH MESH
1
2
3
5

15. POSTERIOR VAGINAL WALL
RECONSTRUCTION WITH MESH
1 2 3
4
5 6 7

16. MESH KIDS FOR DIFFERENT PROLAPSES

18. TOTAL PROLIFT

19. MESH RELATED COMPLICATIONS
(MAUDE DATABASE: 2005-2010
1. Mesh erosion 528 cases
2. Pain 472 cases
3. Mesh Infection 253 cases
4. Bleeding 124 cases
5. Dyspareunia 108 cases
6. Organ perforation 88 cases
7. Urinary problems 80 cases
8. De novo faecal incontinence
9. Hispareunia
10. Necrotizing fasciitis
11. Neuromuscular problems

20. MESH EROSION (BLADDER)

21. MESH EROSION (URETHRA)

22. MESH EROSION (RECTUM)

23. DEFINITION (MESH EROSION)
• Defined as any visible mesh exposure identified on vaginal
examination / visualised on cystoscopy / rectosigmoidoscopy
• May erode the vagina, urethra, bladder or bowel
• Symptoms vary based on the organ involved
• Vaginal bleeding / Abnormal discharge / Dyspareunia / Vaginal pain /
Dysuria / Urinary frequency,urgency,hematuria,recurrent UTI / Urinary
calculi & Urinary fistula
• Variation in the timing; Earliest : 6 weeks; As late as 7 years post-
operatively
• Reported incidence of mesh erosion varies because most of the
published studies have variable methodology, operative
techniques of placement, type of synthetic mesh & reported
length of follow up

24. RISK FACTORS FOR MESH
EROSION
• Age + oestrogen deficiency
• Type & size of synthetic mesh
• Route of surgery / placement
• Method of fixation
• Type & concomitant surgeries

25. MESH RELATED INFECTION
• Incidence ranges from 0 – 8%
• Multifactorial
1. Characteristics of the synthetic mesh
2. Type of procedure
3. Underlying co-morbidity of patient
4. Route of placement
5. Extensive dissection
6. Improper placement
7. Increased tension leading to ischaemia &
increased risk for bacterial colonisation

26. PREVENTION OF MESH EROSION &
INFECTION
1. Anchoring the mesh after being placed
2. Limited dissection + gentle handling of tissues
3. Meticulous attention to hemostasis
4. Peri-operative antibiotics
5. Role of “embedding” the mesh in anti-septic solution prior to
surgery may not play a crucial role (No strong evidence)
6. Role of re-peritonealisation in abdominal sacrocolpopexy also
remains unclear (No RCT to explore this variable)

27. Other mesh related complications …
1. Foreign body reaction
2. Fibrosis
3. Tissue calcification
4. Pain syndromes
5. Recurrent UTI, stone formation
6. Dyspareunia
7. Dyschezia- painful defecation
8. Buttock / Rectal pain in PIVS

28. DE NOVO UI

29. DE NOVO UI
• Interestingly an increased rate of de novo SUI seen in women
who had anterior repair + mesh augmentation
• Hiltunen et al reported de novo SUI in 23% of patients who had
mesh repair compared to a mere 10% of patients who
underwent traditional anterior repair
• An increase in detrusor overactivity was observed in 34% of
patients who has anterior repair + prolene mesh

30. DE NOVO FECAL INCONTINENCE

31. DE NOVO FAECAL INCONTINENCE
• Posterior vaginal wall repairs (Milani et al)
• Social life limitation and less likely to travel to a distant location

32. DYSPAREUNIA/ HISPARENIA

33. DYSPAREUNIA/ HISPARENIA
• Unclear if it arises due to size, type, site & route of placement
of mesh OR by the repair technique
• Unclear if validated questionnaires were used
• Dyspareunia rate of 38% reported with TVM following anterior
repair with Prolene mesh (Milani et al)
• Women may develop de novo dyspareunia without mesh
erosion
• It was an indication for mesh removal in 10 out of 19 women
who had PIVS (Baessler et al)
• “Hispareunia” in some male counterparts” (Brubaker L et al)

34. NECROTIZING FASCIITIS

35. In a nutshell …
• Use of meshes has been an advance & exciting new development
in the surgical management of women with POP
• The effectiveness of synthetic mesh has been demonstrated in
abdominal sacrocolpopexy (Erosion rate : 3.4% cf 10.3% in TVM)
• However, there is a lack of robust evidence to support its routine
use in pelvic reconstructive surgeries; therefore its medicolegal
place is yet to be defined clearly
• Available evidence would suggest that type II & type III meshes
are not recommended due to higher erosion rates & foreign body
reaction as compared to the type I mesh
• RCT are needed on its safety + efficacy
• Safe for SUS & sacrocolppexy, other wise be very selective &
reserve to patients with recurrent POP

36. MESH ALERT !!!

37. TO MESH OR NOT TO MESH?

38. CURRENT ROLE OF MESH IN CLINICAL
PRACTICE- RECOMMENDATIONS BY
ACOG/AUGS
• POP vaginal mesh has been reserved for high-risk individuals in
whom the benefit may justify the risk
• Surgeons should undergo proper training on each and every
device used & experience enough to undertake the surgery
• Patients should provide their informed consent after reviewing
the risk & benefits of the procedure as well as discussing
alternative repairs
• Rigorous comparative effectiveness randomizied trials of the
synthetic mesh & native tissue repair and long term follow-up &
outcomes are needed before definitive conclusion can be made

39. THANK YOU !